Operative treatment of dislocated midshaft clavicular fractures: plate or intramedullary nail fixation? A randomized controlled trial.

BACKGROUND Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. METHODS A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p < 0.05. RESULTS No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). CONCLUSIONS The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant removal.